Laboratory information management system certification means three different things depending on who is speaking, and a small lab manager searching the phrase usually needs to know which one before spending anything. A vendor may mean that its software has been assessed against a standard or validated for a regulated use; an accreditation body means that the laboratory, not its software, has been assessed against a standard such as ISO/IEC 17025 and that its records, whatever system holds them, met it; a training company means that a person has completed a course on a particular product. This page separates the three, says what each does and does not give a small lab, and shows where the free sheets on this site work the figures that matter whichever certification is being discussed.
The software's certification
Some vendors have their systems assessed for information security or validated for use in regulated laboratories, and will say so in the proposal. That tells the lab the software can be operated in a way that meets a standard; it does not mean the lab's use of it does. For a small analytical lab the useful question is narrower: can the system show a result beside its batch's controls, its instrument's calibration and its reagent lot, because that is what the lab's own assessor will ask to see. The quality control sheet and the calibration sheet on this site work what keeping that evidence costs.
The laboratory's accreditation
ISO/IEC 17025 accredits a testing or calibration laboratory; CLIA certifies a clinical one. Neither accredits software. The laboratory's records, quality system and personnel are assessed, and a LIMS is one place those records can live. A small lab pursuing accreditation should read the vendor's claims as claims about the software and its own obligations as its own; the cost per test sheet on this site is where the cost of meeting them belongs, in the overhead line, and the sheet shows what that does to the margin.
The person's certificate
Product training certificates say a person has learned one vendor's system. They are useful when the lab has chosen that system and irrelevant before. The guide this page supports walks how to read a vendor's proposal against the lab's own figures, which is the decision that comes first. Limslane needs no certification to use: the sheets are free and compute on the page, and Limslane Pro keeps a small lab's record at one flat price.
Questions people ask about laboratory information management system certification
Is there a certification for LIMS software?
Vendors may have their software assessed for security or validated for regulated use and will say so; that is a claim about the software, not about the lab's use of it. Ask what evidence the system can show for a result, which is what the lab's assessor will ask.
Does a LIMS certify my laboratory?
No. ISO/IEC 17025 accredits testing laboratories and CLIA certifies clinical ones; both assess the laboratory's records and system, not the software that holds them.
Do I need a LIMS certification course?
Only after choosing a system, and only for that system. Before the choice, work the sheets on this site with your own figures and read the vendor's proposal against them.